Pharmacokinetics, Efficacy, Gametocyte Carriage, Birth Outcomes Following Sulfadoxine-Pyrimethamine Intermittent Presumptive Treatment in Pregnant Women - Full Text View

Sponsor:	University of Cape Town
Collaborators:	Global Fund Medical Research Council, South Africa
Information provided by:	University of Cape Town
ClinicalTrials.gov Identifier:	NCT00380146

Purpose

The main purpose of this study is to compare the drug levels of sulfadoxine-pyrimethamine found when given to pregnant women for the prevention of malaria to those found in pregnant women given the same drug with artesunate for the treatment of malaria, and also with those drug levels found in non-pregnant women in other malaria treatment studies.

Condition	Intervention
Malaria	Drug: sulfadoxine-pyrimethamine

Study Type:	Interventional
Study Design:	Allocation: Non-Randomized Endpoint Classification: Pharmacokinetics Study Intervention Model: Single Group Assignment Masking: Open Label Primary Purpose: Prevention
Official Title:	An Open-Label in Vivo Drug Study to Evaluate the Pharmacokinetics, Therapeutic Efficacy, Gametocyte Carriage and Birth Outcomes Following Sulfadoxine-Pyrimethamine Intermittent Presumptive Treatment (SP IPT) in Pregnant Women

Resource links provided by NLM:

MedlinePlus related topics: Malaria

Drug Information available for: Pyrimethamine

U.S. FDA Resources

Further study details as provided by University of Cape Town:

Primary Outcome Measures:

Pharmacokinetic parameters by measurement of whole blood levels of sulfadoxine and pyrimethamine to determine Cmas, Tmax, AUC, half life, volume of distribution and clearance

Secondary Outcome Measures:

Correlation of treatment outcome and gametocyte carriage with pharmacokinetic parameters and pregnancy status
Correlation of frequency of DHFR mutations at codons 436, 437, 540 and 581 in maternal and placental samples with treatment outcomes
Birth outcomes in terms of major congenital abnormalities, spontaneous abortions, still births and neonatal deaths, gestational age and birth weight, placental weight, newborn head circumference, arm circumference and neurological development
Risk of harm by describing all adverse events and their causality assessments and changes in full blood count, glucose, bilirubin, creatinine, urea and ALT
Capacity building by describing the training and development of study teams and their subsequent skills attained

Estimated Enrollment:	30
Study Start Date:	September 2006
Estimated Study Completion Date:	March 2008

Detailed Description:

Pregnancy increases the risk of malaria progression and complications with up to a 10-fold increase in the malaria case fatality rate in areas of low transmission. Sulfadoxine-pyrimethamine (SP) is used widely in Africa for the systematic intermittent presumptive, or preventive, treatment (IPTp) during the second and third trimester of pregnancy and a national program of IPTp with SP has been implemented recently in Mozambique. There is evidence that the kinetics of several other antimalarial drugs are altered in pregnancy to the extent that doses are not adequate in pregnancy, however no published study has included a pharmacokinetic component to confirm that standard doses of SP are optimal in this vulnerable patient group. This study therefore creates the opportunity to study whether the pharmacokinetic properties of SP are altered by physiological changes that occur during pregnancy.

Eligibility

Ages Eligible for Study:	18 Years and older
Genders Eligible for Study:	Female
Accepts Healthy Volunteers:	No

Criteria

Inclusion Criteria:

Pregnant female, older than 18 years, > 35kg.
Gestational age > 16 weeks (fundal height > 16cm) and below 36 weeks gestation.
Documented informed consent.
Lives close enough to the study site for reliable follow up and is willing to attend ANC and follow-up visits regularly.

Exclusion Criteria:

Diagnoses of uncomplicated acute P. falciparum malaria parasitaemia
Has received anti-malarial treatment in the past 7 days and/or sulfadoxine-pyrimethamine in the past 28 days.
Known hepatic or renal impairment
Has received chloramphenicol, cotrimoxazole or tetracyclines (including doxycycline) in the past 7 days or is likely to require these during the study period.
History of G6PD deficiency.
Has a history of allergy to any of the study drugs (including other sulphonamides e.g. cotrimoxazole).
Serious underlying disease that in the opinion of the clinic team and/or Principal Investigator would make the patient unsuitable for the study in terms of their safety or study analysis.
Imminent delivery expected.
Prior inclusion in this study.

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00380146

Locations

Mozambique
Ndlavela Health Centre
Ndlavela, Maputo, Mozambique

Sponsors and Collaborators

University of Cape Town

Global Fund

Medical Research Council, South Africa

Investigators

Principal Investigator:

Karen I Barnes, MBChB

University of Cape Town

More Information

No publications provided

ClinicalTrials.gov Identifier:	NCT00380146 History of Changes
Other Study ID Numbers:	SEACAT2.2
Study First Received:	September 22, 2006
Last Updated:	April 23, 2007
Health Authority:	Mozambique: Ministry of Health (MISAU)

Keywords provided by University of Cape Town:

Malaria
Intermittent presumptive treatment
IPT
Pharmacokinetic

Efficacy
Gametocyte
Molecular markers

Additional relevant MeSH terms:

Malaria
Protozoan Infections
Parasitic Diseases
Pyrimethamine
Sulfadoxine
Sulfadoxine-pyrimethamine
Antimalarials
Antiprotozoal Agents
Antiparasitic Agents

Anti-Infective Agents
Therapeutic Uses
Pharmacologic Actions
Folic Acid Antagonists
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action
Anti-Infective Agents, Urinary
Renal Agents

ClinicalTrials.gov processed this record on May 24, 2012